| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00473-1 |
| Product Name/Description |
Codman Certas Programmable Valves (Hydrocephalic valve)
In Line Valve only with SIPHONGUARD Device
Product Code: 82-8804
In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories
Product Code: 82-8806
ARTG Numbers: 186235 and 190248 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson testing has shown that, in a small percentage of valves, the following conditions may exist:
1. The MRI resistance feature may not always operate properly. If this occurs, it could potentially result in an unintended change in the valve setting due to exposure to an MRI procedure or other magnetic field. Based on reported complaints, this issue may have been a factor in up to 0.06% of units sold.
2. The programming mechanism may not always operate properly. If this occurs, it could potentially lead to an inability to modify the operating pressure of the valve with the hand-held programming tools, also referred to as the CODMAN CERTAS Therapy Management System (TMS). Based on reported complaints, this issue may have been a factor in up to 0.4% of units sold. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
JJM is recalling the affected units that have not been implanted. For patients that have already been implanted with the device, JJM is providing additional instructions to clinicians to identify whether the implanted device has been affected and what actions to undertake if the device has been affected. For more details, please see http://www.tga.gov.au/safety/alerts-device-codman-certas-valves-130527.htm .
This action has been closed-out on 29/01/2016. |
| Contact Information |
1800 252 194 - Johnson & Johnson Customer Service |